Infusion device

ABSTRACT

The present invention relates to an infusion device comprising a housing; a compartment inside said housing for positioning a medicament container, an infusion needle arranged to said housing, being connectable to said medicament container for delivering a dose of medicament, a piston plunger arranged in said housing capable of acting on said medicament container for delivering a dose of medicament, mechanical drive means capable of acting on said piston plunger for delivering a dose of medicament. The invention is characterised in that said piston plunger comprises a number of distinct segments being inter-connectable to each other for forming an elongated piston plunger.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/657,089, filed Oct. 18, 2019, which is a continuation ofU.S. patent application Ser. No. 15/989,516, filed May 25, 2018, nowU.S. Pat. No. 10,518,029, which is a continuation of U.S. patentapplication Ser. No. 14/391,947, filed Oct. 10, 2014, now U.S. Pat. No.10,251,995, which is a U.S. National Phase Application pursuant to 35U.S.C. § 371 of International Application No. PCT/EP2013/057326 filedApr. 8, 2013, which claims priority to U.S. Provisional PatentApplication No. 61/622,252, filed Apr. 10, 2012 and Swedish PatentApplication No. 1250358-7 filed Apr. 10, 2012. The entire disclosurecontents of these applications are herewith incorporated by referenceinto the present application.

TECHNICAL AREA

The present invention relates to an infusion device and in particular toa compact and easy to use mechanical driven infuser.

BACKGROUND

For a number of years infusers have been used that provides the patientor user with the means of administering a drug in an easy way withoutthe need for a medically trained person, such as a physician or nurse tohandle the device.

One drawback with these infusers is that they have a medicamentcontainer of a certain length as well as a plunger rod acting on saidmedicament container for delivering a dose of medicament, also having acertain length, whereby the total length of a device has to be at leastthe length of the medicament container and the plunger rod. If a drivemember is used, such as for instance a drive spring, the length of thedevice is further increased.

One way of handling this is to make at least the plunger rod shorter ornot adding so much to the overall length. One solution to this is tohave a flexible plunger rod, which is disclosed for example in EP 1 583573 where the plunger rod may be bent or formed as a circle. Anothersolution is disclosed in EP 1 276 529 having a bendable plunger rod witha ratchet on a side surface, where the plunger rod is bent around acogwheel, for driving the plunger rod.

The drawback with these solutions is that the length may not beincreased by the whole length of the plunger rod, but at least by someamount because the circle formed by the bent plunger rod also adds tothe length. Further, the dimensions of the device in other directionsare increased considerably by these solutions, providing a rather bulkydevice.

The above mentioned solutions utilize some sort of power spring woundaround a shaft or the like positioned in the centre of the circle formedby the curved plunger rod. These power springs often act directly oralmost directly on the curved plunger rod, such as with the device of EP1 276 529 where the power spring acts on the cog wheel.

The drawback with this drive solution is that it complicates theaddition of functions such as activation mechanisms, constant infusionspeed mechanism, automatic stop mechanisms, just to mention a few. Thisis mainly because the plunger rod surrounds and thereby blocks access tothe plunger drive spring without enlarging the device.

Regarding the infusion speed control aspect, some solutions have beendevice, such as for example in EP 1 326 659 where an electric motor isutilized for driving the flexible plunger rod. Also document WO2010/112377 discloses a device utilizing electric motors for driving andcontrolling the movement and speed of the plunger rod.

The drawback with this is that the device has to rely on electric powerin order to deliver a dose of medicament. If any batteries used aredepleted, the device cannot be used at all, which may be critical forsome types of drugs.

SUMMARY

The aim of the present invention is to remedy the above drawbacks withthe state of the art devices.

According to one major aspect of the invention the piston plungerpreferably comprises a number of distinct segments beinginter-connectable to each other for forming an elongated piston plunger.In this aspect it is to be noted that the segments are not connected toeach other beforehand. They are each distinct separate components thatcan be positioned inside the device in many ways.

The segments have members that provide a connection between thesuccessive segments such that adding and connecting of segments forms anelongated piston plunger. This provides an advantage in that the spacerequired for the plunger rod segments is much lesser than the spacerequired for a flexible piston plunger. The interconnection of thesegments preferably provides a locking in the longitudinal direction ofthe piston plunger, thereby acting as if it was a solid plunger rod.

The segments may be interconnected successively during delivery of adose of medicament, whereby a subsequent segment is put in position andinter-connected with a previous segment as the piston plunger advancesduring infusion. This provides the possibility of arranging the segmentsin a pile or stack, in turn providing as very compact and space-savingdesign of the piston plunger. It is of course feasible to have more thanone pile or stack of segments.

In order to advance and position subsequent segments of the pistonplunger, especially when placed in a stack, a force member may beprovided, capable of acting on said stack of piston plunger segments forsuccessively interconnecting piston plunger segments. The force membermay then act on the whole stack or pile, pushing on the last segment tobe inter-connected so that each subsequent segment is pushed into placein relation to a previous segment. The force member may be a springmember or the like being in a tensioned state before activation of theinfusion and the inter-connection of the segments.

Preferably the piston plunger is threaded and cooperates with a drivenut for the advancement of the piston plunger during infusion. In thisaspect, the piston plunger segments are arranged with threads, designedto interact with the drive nut connected to said mechanical drive means.

An advantageous design of the piston plunger segments regarding bothpiling in stacks and interacting with a drive nut, the segments have agenerally rectangular cross-section and having thread segments on thecorners of the rectangles.

Further, in order to have a compact mechanical drive means, it maycomprise a flat spiral spring preferably arranged in a rotatable springhousing. Thereby the length of the device is not affected by themechanical drive means acting on the piston plunger. Rather, when arotating spring housing is provided, a compact a drive member arrangedbetween said spring housing and said drive nut may be arranged.

The device may further comprise an infusion speed control mechanismoperatively connected to said mechanical drive means if that is arequirement. Preferably the infusion speed control mechanism comprises acentrifugal brake. The advantage with this is that a purely mechanicalspeed control may be obtained, thereby avoiding any electrically drivensolutions. A mechanical centrifugal brake is also not so space-consumingand may be made very compact. In order to provide a proper function ofthe centrifugal brake, a transmission may be arranged between saidmechanical drive means and said centrifugal brake.

Preferably the device may further comprise a penetration mechanism,capable of extending said infusion needle into an infusion site. Therebythe user does not necessarily have to perform the penetration manually,which is an advantage for some users who do not like the concept ofneedles and the penetration thereof. Then a penetration performed by thedevice is preferable. In addition to the penetration the penetrationmechanism may further be capable of retracting said infusion needle uponcompletion of dose delivery. Then the device is harmless after performedinfusion and the risk of unintentional needle sticks is removed.

The device may further be arranged with a manually operable operationmechanism, for activating delivery of a dose of medicament, such as aturnable knob, wherein turning of the knob a certain rotational distanceactivates the penetration mechanism. A turnable knob is an intuitivecomponent that a user has no problems as how to handle. The turningmotion of the knob may also be advantageous in that it may easily betransferred to other components of the device for initiating and/orperforming additional functions, such as activating of infusion andwithdrawal of the infusion needle.

These and other aspects of, and advantages with, the present inventionwill become apparent from the following detailed description of theinvention and from the accompanying drawings.

BRIEF DESCRIPTION OF THE FIGURES

In the following detailed description of the invention, reference willbe made to the accompanying drawings, of which

FIG. 1 is a side view of an embodiment of the present invention,

FIG. 2 is a side view of the device of FIG. 1 turned 180 degrees,

FIG. 3 is an exploded view of the device of FIG. 1 ,

FIG. 4 is a partly exploded view of the device of FIG. 1 with theproximal housing part removed for clarity,

FIG. 5 is a partly exploded view of the device of FIG. 1 with the distalhousing part removed for clarity,

FIG. 6 a is a detailed view of the piston plunger comprised in thepresent invention,

FIG. 6 b is a detailed view of a piston plunger segment comprised in thepiston plunger according to the present invention,

FIG. 7 a is a detailed view of the piston plunger according to theinvention with a spring unit and follower,

FIG. 7 b is a detailed view of a magazine to house the piston plunger,

FIG. 8 shows a partly exploded view of the device according to FIG. 1 ,

FIG. 9 shows a partly exploded view according to FIG. 8 and turned 180degrees,

FIG. 10 shows a partly exploded view of a penetration mechanismaccording to one aspect of the invention,

FIG. 11 shows a further partly exploded view of the penetrationmechanism,

FIG. 12 show a perspective view of the device of FIG. 1 with the distalhousing part removed for clarity,

FIG. 13 shows a perspective view of the device of FIG. 1 with theproximal housing part removed for clarity,

FIG. 14 shows a view of the distal housing part and a part of anoperation mechanism,

FIG. 15A shows details views of a knob comprised in the presentinvention,

FIG. 15B shows details views of a knob comprised in the presentinvention,

FIG. 16 shows a detailed view of a component comprised in an auto-stopmechanism,

FIGS. 17 to 29 show different functional positions of the device duringuse.

DETAILED DESCRIPTION

The embodiment of an infusion device shown in the drawings comprises ahousing, which may be in two housing parts 10, 12. It is of coursefeasible that it comprises more than two housing parts. Preferably, thecomplete housing has a generally rectangular shape having a measure orthickness as seen along a proximal-distal axis 14 that is much less thanthe dimensions in the other two directions, vertical 16 and horizontal18. The housing is arranged with an operating means, 20 in theembodiment shown as a turnable knob on the distally directed housingsurface.

On the proximally directed housing surface, an opening is arranged,through which an Allen keyhole 22 is accessible, FIG. 2 . The Allenkeyhole 22 is arranged on a shaft 24, FIG. 4 , rotatably arranged insidethe housing and journalled with a distal end in a seat 26 on the innersurface of the distal housing part 10. A proximal end of the shaft 24 isarranged with a number of arms 28 that extend from a hub 30 in agenerally circumferential direction. The free ends of the arms 28 arearranged with radially outwardly directed edges 32. The hub 30 with thearms 28 is intended to fit into a seat 34, FIG. 5 , on the inner surfaceof the proximal housing part 10. The seat 34 is surrounded by an annularledge 36 having radially inwardly directed teeth 38 of a certainconfiguration. The teeth 38 are intended to cooperate with the free endsof the arms 28 as will be described.

The shaft 24 is further arranged with a slit 40, FIGS. 4 and 5 , alongits length. Further, around the shaft 24 is a flat spiral spring 42,FIG. 4 , wound, wherein the inner end of the spiral spring 42 fits intothe slit 40, thereby locking the spring 42 to the shaft 24. The spring42 is further arranged inside a spring housing 44 designed as agenerally tubular part. The inner surface of the tubular part isarranged with a locking segment 46, FIG. 4 , into which an outer end ofthe spiral spring 42 fits, thereby locking the spiral spring 42 to thespring housing 44. The spring housing 44 is further arranged with asidewall 48, FIG. 5 , having a central opening 50, through which theshaft 24 can extend. On the outer circumferential surface of the springhousing 44 a ratchet 52 is arranged. The ratchet 52 is intended tocooperate with a cogwheel 54 of a drive member 56, where the cogwheel 54preferably is bevelled. The drive member 56 comprises a shaft 56 wherethe cogwheel 54 is attached to one end such that the shaft 56 extendsgenerally in the radial direction of the spring housing 44 as seen inFIG. 4 along line 58. The shaft 56 is journalled in the proximal housingpart 10 by support members 60, FIG. 5 . A second cogwheel 62 is arrangedat the second end of the shaft 56, FIG. 5 . The second cogwheel 62 isarranged to be in contact with teeth 64 of a drive nut 66, where theteeth 64 extend around the circumference of the drive nut 66. The drivenut 66 is further arranged with a central opening 68, FIG. 4 , whichopening 68 is arranged with threads 70. The threads 70 of the drive nut66 are intended to interact with a threaded piston plunger 72. Thespring housing 44 is further arranged with indicia or markings 73, FIG.5 , in the embodiment shown a series of curved lines on the outersurface of the sidewall 48. These markings 73 are visible in a window oropening 75 on the distal housing part FIG. 1 , as will be explainedbelow.

In the embodiment shown the piston plunger is of a certainconfiguration, FIG. 6 a, b. The piston plunger generally has arectangular configuration as seen in a cross-sectional view. Each cornerof the rectangular piston plunger 72 is arranged with thread segments74. Further the piston plunger is divided up into a number of pistonplunger segments. The end of the first piston plunger segment 76 that isto be in contact with a medicament container 78, FIG. 3 , is arrangedwith a generally circular pusher plate 80 having a diameter somewhatless than the inner diameter of the medicament container. The firstpiston plunger segment 76 has a certain length. The following pistonplunger segments 82, FIG. 6 a , are somewhat shorter. All piston plungersegments are arranged with connection members that comprise generallyvertically arranged cut-outs 84 at their distal ends. The side walls 86of the cut-outs 84 are arranged with generally vertically directedgrooves 88, having a certain configuration. Further, each piston plungersegment apart from the first segment, is arranged with a proximallydirected nose 90 designed to fit into the cut-out 84 of a previousplunger segment 82. Further the nose 90 is arranged with generallyvertically extending ledges 92 having similar configuration as thegrooves 88 of the cut-out 84, whereby the ledges 92 may fit into thegrooves 88 as seen in FIG. 6 b.

The piston plunger segments 82 are arranged in a generally verticalstack on top of each other and directed such that the corners with thethread segments extend generally horizontally, FIG. 7 a . The stack ofpiston plunger segments is held in place inside the housing by amagazine 94 providing side supports on three sides. The fourth side isarranged with an elongated slit 96, FIG. 7 b . In the slit a flat bandspring 98 is arranged having a first upper end attached to a fixturepost 100 on the magazine 94, FIG. 7 a . The second lower end is attachedto a piston plunger follower 102 inside that magazine 94, FIG. 7 a . Thefunction of the described components will be explained below.

The proximal end of the piston plunger 72 extends into a space in thedevice intended to accommodate the medicament container 78, FIG. 8 . Thespace is accessible via a hingedly attached lid 104, FIG. 1 , on anupper area of the housing. Inside the space a holder or cartridgeretainer 106, FIG. 3, 11 , is arranged, on which the medicamentcontainer may be placed. The cartridge retainer 106 is arranged slidablein a longitudinal direction inside the housing guided by itslongitudinal edges 108, FIGS. 8 and 9 , fitting into guides 110 on eachhousing part, FIG. 8 . Further a cogwheel segment 111 of a cartridge cam112, is turnably attached to posts 114, FIG. 9 , on the proximal housingpart 12. An upper surface of the cartridge cam 112 is arranged with acurved ridge 116, FIG. 9 , which ridge cooperates with downwardlydirected protrusions 118 on the underside of the cartridge retainer 106.The cogwheel segment 111 of the cartridge cam 112 is further connectedto a ratchet segment 120, FIG. 9 , arranged on an outer surface of theoperation member 20, in the embodiment shown a turnable knob. Thefunction of the knob and the cartridge cam will be explained in detailbelow.

The cartridge retainer 106 is further arranged with an end piece 122,FIG. 9 , which is intended to be in contact with an end of the container78, comprising a septum (not shown). The end piece 122 is furtherarranged with a hollow needle piece 124, FIG. 9 , intended to pierce theseptum of the container, as will be described. The needle piece 124extends through the end piece and is further provided with a bend ofgenerally ninety degrees. At the lower end of the needle piece, a firstend of a flexible tube 126 (not shown) is attached. Further, a secondend of the flexible tube is attached to a distal end of an infusionneedle 128, FIG. 10 . The infusion needle is attached to a generallycylindrical needle hub 130, which in turn is positioned inside agenerally cylindrical needle plunger 132. The needle plunger 132 is inturn positioned inside a generally tubular guide piece 134, being a partof the proximal housing part 10. A lower end of the guide piece is opentowards the proximal direction and the opening is arranged with aruptable membrane 136. The needle plunger 132 is further arranged withtransversally extending arms 138, FIGS. 10 and 11 . Each arm is arrangedwith a chamfered side surface 140, which chamfered surfaces 140 areintended to cooperate with ledges 142, FIG. 5 , on an inner surface ofthe knob 20. The needle plunger 132 is urged in the distal direction bya spiral spring 143 acting between the transversal arms 138 and theinner surface of the proximal housing part, FIG. 10 .

The device is further arranged with an infusion speed control mechanism144, that preferably is capable of providing a constant infusion speedduring the infusion. It comprises a transmission, FIGS. 12 and 13 , witha first cogwheel 146, FIG. 12 , with a small diameter acting on theratchet 52 on the outer surface of the spring housing 44. The firstcogwheel 146 is attached to a second cogwheel 148 having a largerdiameter, wherein the first and second cogwheels 146, 148 are rotatablyarranged to a first shaft 150. The second cogwheel 148 is in engagementwith a third cogwheel 152 having a smaller diameter. The third cogwheel152 is attached to a fourth cogwheel 154 having a larger diameter. Thethird and the fourth cogwheel 152, 154 are rotatably arranged to asecond shaft 156. The fourth cogwheel is then in engagement with a fifth158 cogwheel having a smaller diameter, FIG. 13 . The fifth cogwheel 158is attached to a sixth cogwheel 160 having a larger diameter. The fifthand the sixth cogwheels 158, 160 are rotatably arranged to a third shaft162. The sixth cogwheel 160 is in engagement with a seventh cogwheel164. The seventh cogwheel 164 is attached to a centrifugal brake 166,comprising a number of arms 168 attached to a hub 170, FIG. 12 , wherethe seventh cogwheel 164 and the hub 170 are rotatably arranged to afourth shaft 172. The arms 168 of the centrifugal brake 166 extendgenerally in circumferential direction, having their free ends becomingtrailing ends when the hub rotates. The outer surfaces of the arms 168are arranged with ledges 174. The hub 170 with its arms 168 ispositioned in a generally tubular piece 176 attached to the innersurface of the distal housing part 12. The diameter of the tubular piece176 is chosen such that there is a small gap between the ledges 174 ofthe arms 168 and the inner surface of the tubular piece 176 when the hub170 is not rotating. The centrifugal brake 166 is further arranged withtransversally extending arms 178 attached to the hub 170. The free endsof the arms 178 are arranged with end pieces 180, FIG. 14 , extendinggenerally perpendicular to the extension of the arms 178.

The device is further arranged with an operation mechanism 182. Theoperation mechanism 182 comprises the previously mentioned knob 20, FIG.14 . Further, it comprises a start linkage 184 designed with an arm 186attached to a cylindrical hinge 188 fitting into a post 190 in theproximal housing part 10. The arm 186 extends towards and into the knob20. At the end of the arm a contact surface 192 is arranged, which isintended to interact with a protrusion 194 inside the knob 20, as willbe explained. Further the arm 186 of the start linkage 184 is arrangedwith a branch 196 extending towards the centrifugal brake 166, andintended to interact with the end pieces 180 of the transversal arms 178of the hub 170. At an inner end of the arm 186 a spring element 198 isarranged.

The operation mechanism is further arranged with a movement memberarranged as a spring 200 provided with two arms 202, 204, each in turnarranged with an end piece 206, 208 directed generally perpendicular tothe arms 202, 204. The first end piece 206 of the spring is attached tothe distal housing part, FIG. 12 . The second end piece is in an initialposition held by a hook 210, FIG. 12 , adjacent the opening in thedistal housing part intended for the knob 20. When the knob is operatedduring use, as will be described, the second end piece will fit into aseat 212 in a generally radially protruding ledge 214 attached to theknob, FIG. 15 .

The device is further arranged with an auto-stop mechanism 216, FIG. 11. It comprises a beam 218 provided with a proximal end 220, FIG. 15 .The proximal end 220 is arranged with a downwardly directed ledge 222,intended to be in sliding contact with a curved surface 224, FIG. 12 ,on the inner surface of the proximal housing part 10. Further a flexiblearm 226 is arranged on a side surface of the beam 218, the arm 226 beingflexible in the proximal-distal direction 14. The arm 226 is arrangedwith a distally directed ledge 228, the ledge being provided with abevelled surface 230. The arm 226 and the ledge 230 are arranged to comein contact with a proximally directed protrusion 232 on the knob 20,FIG. 15 . The protrusion of the knob is also arranged with a bevelledsurface 234, intended to interact with the bevelled surface 230 of thearm 210 of the beam 202, as will be explained. Further, the proximalpart of the beam 218 is arranged with an arm 236 extending from theunderside of the beam 218 and towards the spring housing 44 as seen inFIG. 13 . The free end of the arm 236 is arranged with a downwardlydirected protrusion 238, which protrusion 238 is intended to interactwith a groove 240, FIGS. 4 and 13 , arranged on the outer surface of thespring housing 44, as will be explained.

The beam 218 is arranged with a distal part 242 being directed moreupwards than the proximal part as seen in FIG. 12 , giving the beam acurved shape as seen in the proximal direction of the device. The upperend 244 of the distal end of the beam 218 is positioned adjacent thedrive nut 66 and the piston plunger 72, FIG. 12 , for reasons that willbe explained below.

Intended Function of the Device

The device is usually delivered without a medicament container. Thus,before use, a medicament container 78 has to be inserted into thedevice. The lid 104 at the upper end of the device is then opened, FIG.17 , whereby the space and the cartridge retainer 106 are accessible.The medicament container 78 is then inserted with a neck portion towardsthe end piece 122 of the cartridge retainer 106. The lid is then closed.

The device is now made ready. This may be done by inserting an allen keyinto the hole 22 on the proximal surface of the device and turning theshaft 24 in the anti-clockwise direction. This causes the arms 28 of thehub 30 to slide over the teeth 38 because of the direction of the armsin relation to the teeth. Because the inner end of the spiral spring isattached to the turning shaft 24 the spiral spring is tensioned. Whenthe user stops turning the shaft, it is locked against rotating backbecause of the edges 32 of the arms now locking against the teeth 38.The device is now ready for delivering a dose of medicament.

In the initial position, the knob is in the rest or delivery position asseen in FIG. 17 . In this position, as seen in FIG. 128 , the ratchetsegment 120 of the knob 20 is not yet in engagement with the cartridgecam. The contact surface 192 of the operation mechanism 182 is on theinner surface of the knob, unaffected. As seen in FIG. 19 , thisposition of the operation mechanism causes the branch 196 to be in thepath of the end pieces 180 of the arms 178 of the hub 170, wherebyrotation of the hub 170 of the constant speed control mechanism 144 isprevented. The process up to this point may be done without the devicebeing in contact with the patient. In order to be able to deliver a doseof medicament to the patient, the proximal surface of the device has tobe in contact with some part of the body of the patient, i.e. toreleasably attach the device to the body. This may be performed in manyways, by straps, by merely pressing it manually, but preferably theproximal surface is arranged with some sort of adhesive, like stickytape, with which the device may be fastened to the body. One variant isto have double-sided sticky tape on the proximal surface with an outerprotective layer that is peeled off before attachment.

When the device is activated, the user initially turns the knob to thefirst position, as seen in FIG. 1 , displaying the pause sign. Thisturning of the knob causes its ratchet segment 120 to engage thecogwheel segment 111 of the cartridge cam, whereby the cartridge cam isturned around its contact point with the proximal housing part. Theturning of the cartridge cam causes in turn the curved ridge 116 to acton the protrusions 118 of the cartridge retainer 106, causing thecartridge container 106 to be moved linearly, guided by the guides forthe cartridge retainer 110, such that the end piece 122 is movedtowards, and in contact with, the neck portion of the medicamentcontainer 78. The medicament container 78 is in turn held inlongitudinal position by the proximal end of the piston plunger 72 withthe pusher plate 80 being in contact with the stopper of the medicamentcontainer. The movement of the end piece causes the needle piece 124 topenetrate the septum of the medicament container, thereby creating apassage for the medicament through the septum. The medicament can nowflow into the flexible tube and to the infusion needle.

The turning of the knob also initiates the penetration by the infusionneedle. The ledges 142 on the inner surface are inclined, as seen inFIG. 20 and in FIG. 15 , and the chamfered surfaces 140 of thetransversal arms 138 of the needle plunger 132, will slide on theseinclined surfaces, whereby the needle plunger 132 is pushed in theproximal direction against the force of the needle plunger spring 143.The infusion needle will rupture the membrane 136 and extend out of thedevice as shown in FIG. 20 .

Initiation of Infusion

In order to start the infusion, the user turns the knob a step furtherto the position indicated by a “play” arrow, FIG. 21 . This causes theprotrusion 194 inside the knob 20, FIG. 22 , to come in contact with thecontact surface of the start linkage 184, whereby it will turn aroundits hinge 188. The turning of the start linkage will cause the branch196 to move out of contact with the end pieces 180 of the arms 178 ofthe hub, whereby the hub is free to rotate, FIG. 23 . Because of thechain of cogwheels of the transmission of the speed control mechanism,the spring housing 44 is free to rotate due to the force of thetensioned flat spiral spring 42. The knob is held in this position inthat the end piece of 208 of the spring during rotation is moved fromthe hook 210 to the seat 212 of the ledge 214 of the knob 20, FIG. 22 .This new position of the spring will urge the knob to turn in thisdirection. However, the knob is prevented from turning further becausethe protrusion 232 of the knob 20 with its bevelled surface 234 is incontact with the bevelled surface 230 of the ledge 228 of the flexiblearm 226, FIG. 24 .

Infusion Operation

The rotation of the spring housing 44 will cause its ratchet 52 to movearound the circumference, thereby acting on the cogwheel 54 of the drivemember. The rotation of the second cogwheel 62 of the drive member 54will, due to the engagement with the drive nut 66, cause the latter torotate. In turn, the rotation of the drive nut 66 will cause the pistonplunger 72 to move in the proximal direction by the engagement betweenthe drive nut and the thread segments 74. When the first piston plungersegment 76 has moved a distance in the proximal direction, the spacebehind the first segment is so large that a subsequent piston plungersegment 82 may be pushed in the vertical direction by the flat bandspring 98 acting on the lowermost positioned piston plunger follower102. When the following piston plunger segments are pushed upwards inthe vertical direction, they are connected to a previous piston plungersegment in that the ledges 92 of the nose 90 of the subsequent segmentfit into the grooves 88 of the cut-out 84 of the previous segment,thereby sequentially “building” a continuous piston plunger 72 with thesegments. The process of the infusion sequence is also visible in theopening 75 where the indicia 73 on the spring housing 44 pass

Speed Control of Infusion

The movement of the piston plunger 72 in the proximal direction willcause the stopper of the medicament container to move inside thecontainer, whereby medicament is pushed through the needle piece 124,the flexible tube 126 and the infusion needle 128. A constant speed ofthe piston plunger 72 is ascertained by the constant speed controlmechanism in that the rotation of the spring housing 44 is transmittedto the hub 170 of the centrifugal brake 166 via the transmission ofcogwheels 146, 148, 152, 154, 158, 160 and 164. The rotation of the hub170 will cause the arms 168 to move in the radial direction if the speedis increased over a pre-set level. The movement in the radial directionwill cause the ledges 174 of the arms 168 to be moved in contact withthe tubular piece 176, causing a contact friction between the ledges ofthe arms and the tubular piece that will reduce the speed. In thismanner the speed will be kept more or less constant when the arms aremoved in and out of contact with the tubular piece during rotation.

Pausing of the Infusion

The user may pause the infusion by turning the knob 20 back to the“pause” position against the force of the spring 200. This will causethe contact surface 192 of the start linkage 184 to move out of contactwith the protrusion 194 of the knob, which in turn will cause the startlinkage to swing back to its initial position by the spring element 198.This in turn will cause the branch 196 to move in the path of the endpieces 180 of the arms 178 of the hub 170, whereby the rotation of thehub is blocked. This in turn will stop the rotation of the springhousing 44 via the transmission, and also the rotation of the drive nut,thereby stopping the movement of the piston plunger 72.

Auto-Stop Function

When the infusion sequence is about to end when the medicament containerhas been emptied, there will be a space 246 behind the last of thepiston plunger segments 82, FIG. 25 . Because the upper end 244 of thebeam constantly has been in contact with and underside of the pistonplunger, it is now free to move upwards into the space. Due to this andthe form of the beam, the arm 236 is moved towards the spring housing,whereby the protrusion 238 of the arm 236 comes in contact with theouter surface of the spring housing 44 and when the groove 240 of thespring housing comes in position in relation to the protrusion, thelatter will be forced into the groove and the rotation of the springhousing is blocked, FIG. 26 .

When the protrusion 238 enters the groove 240 the force of the spiralspring on the spring housing will cause the beam to be lifted somewhatin the vertical direction. This movement of the beam will cause theflexible arm 226 and its ledge to be moved out of contact with theprotrusion of the knob 232 FIG. 27 . Due to the force of the spring 200acting on the knob 20 and urging it in the clock-wise direction, theknob will be turned in this direction. On the inner surface of the knob,the ledge that the transversal arm is resting on is terminated at 246,FIGS. 27 and 15 b, whereby the needle plunger is free to be moved in thedistal direction by the needle plunger spring 143. This now causes theinfusion needle to be withdrawn from the infusion site. The device maynow be removed and discarded.

Manual Stop

Instead of the automatic stopping of the device, it may be stoppedmanually by turning the knob further, FIG. 1 , against the force betweenthe flexible arm 226 and the protrusion 232 of the knob, FIG. 28 . Thiswill cause the flexible arm 226 to move in the proximal direction suchthat the protrusion 232 of the knob can pass. The arm will then flexback whereby the ledge 228 of the arm 226 prevents the user from turningback the knob. At the same time, the contact surface 192 of the startlinkage 184 is moved out of contact with the protrusion 194 of the knob,which will stop the rotation of the spring housing 44 via thetransmission in the same manner as when the infusion is paused asdescribed above. However, in this position, the knob may not be turnedback, thereby avoiding unintentional activation of the device again.Further, in this position, the ledge that the transversal arm is restingon is terminated, whereby the needle plunger is free to be moved in thedistal direction by the needle plunger spring, in the same manner aswith the auto-stop function. This now causes the infusion needle to bewithdrawn from the infusion site. The device may now be removed anddiscarded.

It is to be understood that the embodiment described above and shown inthe drawings is to be regarded only as a non-limiting example of theinvention and that it may be modified in many ways within the scope ofthe patent claims.

1. A medicament delivery device, comprising: a housing; a cartridgeretainer positioned within the housing and having a longitudinal axis; aneedle having a starting stationary position where the needle iscompletely within the housing and being in fluid communication with amedicament container positioned within the cartridge retainer so that adose of medicament is delivered through the needle, where the needle ismovably arranged within and relative to the housing, where the needlehas a proximal end that moves from the starting stationary position to asecond position that is extended to a position outside the housing, andwhere the movement of the needle from the starting stationary positionto the second position defines an axis of movement; and a piston plungerdisposed within in the housing, where the piston plunger comprisesmovable segments that define a first portion and a second portion, wherea pusher plate is positioned on the first portion such that the pusherplate extends into the medicament container during delivery of the doseof medicament, wherein the piston plunger moves parallel to thelongitudinal axis of the cartridge retainer in a direction that isgenerally transverse to the axis of movement of the proximal end of theneedle; wherein the proximal end of the needle moves to the secondposition before delivery of the dose of the medicament begins.
 2. Themedicament delivery device of claim 1 further comprising a tube fixed toa distal end of the needle, where the needle hub moves in a directiongenerally transverse to the movement of the piston plunger.
 3. Themedicament delivery device of claim 1 further comprising tubing that isin fluid communication with the needle and the medicament within themedicament container when positioned within the cartridge retainer. 4.The medicament delivery device of claim 1, where the needle when in thesecond position is locked relative to the housing to prevent movement ina distal direction.
 5. The medicament delivery device of claim 1 furthercomprising a biasing member operatively associated with the housing tomove the needle relative to the housing.
 6. The medicament deliverydevice of claim 1 further comprises a driver operatively engaged withthe piston plunger to move the piston plunger parallel to thelongitudinal axis to deliver the dose of medicament.
 7. The medicamentdelivery device of claim 6, further comprising an injection speedcontrol mechanism operatively connected to the driver.
 8. The medicamentdelivery device of claim 1 further comprises an operation member thatprotrudes from the housing and is accessible to a user to activate themedical device.
 9. The medicament delivery device of claim 1 wherein theproximal end of the needle is covered by a membrane when the needle isin the starting stationary position within the housing and the needle isin fluid communication with the medicament container prior to the needlemoving relative to and exiting from the housing.
 10. The medicamentdelivery device of claim 1 wherein a part of the housing is removable toallow user access to the cartridge retainer.
 11. The medicament deliverydevice of claim 1 wherein the housing has a length at least equal to alength of the cartridge retainer as measured along the longitudinalaxis.
 12. A medicament delivery device, comprising: a housing; acartridge retainer having a longitudinal axis and located within thehousing; an operation member that protrudes from the housing and isaccessible to a user; a needle having a proximal end and having astarting stationary position where the needle is completely within thehousing such that the needle is in fluid communication with a medicamentcontainer positioned in the cartridge retainer prior to the needlemoving relative to and exiting from the housing so that a dose ofmedicament is delivered through the needle, where the proximal end ofthe needle moves from the starting stationary position within thehousing to a second position that is extended to a position outside thehousing and where the movement of the needle from the first position tothe second position defines an axis of movement; a piston plungercomprising a stack of segments disposed within in the housing, where afirst portion of the piston plunger extends into the medicamentcontainer during delivery of the medicament and a second portion of thepiston plunger is operatively engaged with a driver that causes thefirst portion to move parallel to the longitudinal axis of the cartridgeretainer in a direction that is generally transverse to the axis ofmovement of the proximal end of the needle; and an injection speedcontrol mechanism operatively controlling the driver and movement of thepiston plunger, wherein the proximal end of the needle moves to thesecond position before delivery of the dose of the medicament begins.13. The medicament delivery device of claim 12, where upon completion ofthe medicament delivery the needle moves distally from the secondposition to a third position where the needle is retracted to a positioninside the housing to prevent unintentional needle sticks.
 14. Themedicament delivery device of claim 12 further comprising a window inthe housing to allow a user to monitor medicament delivery progress. 15.An medicament delivery device, comprising: a housing; a compartmenthaving a longitudinal axis and positioned inside the housing for holdinga medicament container; a needle connected to a flexible tube andmovably arranged within the housing and in fluid communication with themedicament container through the flexible tube for delivering a dose ofmedicament, where the needle has a proximal end that moves from a firstposition within the housing to a second position that is extended to aposition outside the housing, where the movement of the needle from thefirst position to the second position defines an axis of movement; apiston plunger disposed in the housing for acting on the medicamentcontainer to deliver the dose of medicament, where a front portion ofthe piston plunger moves parallel to the longitudinal axis of thecompartment in a direction that is transverse to the axis of movement ofthe proximal end of the needle and where the second portion of thepiston plunger moves transverse to the longitudinal axis of thecompartment; and a driver operatively engaged with the second portion ofthe piston plunger to deliver the dose of medicament, wherein when themedicament device is activated, the proximal end of the needle moves tothe second position before delivering the dose of the medicament. 16.The medicament delivery device of claim 15, wherein the piston plungerfurther comprises a stack of segments positioned inside and supported bya magazine.
 17. The medicament delivery device of claim 15, wherein thepiston plunger has a generally rectangular cross-section.
 18. Themedicament delivery device of claim 15, wherein the plunger pistonfurther comprises a number of distinct separate segments that aresuccessively interconnected during delivery of the dose of medicament.19. The medicament delivery device of claim 15, wherein an intersectionof the first portion with the second portion defines a generally90-degree angle.
 20. The medicament delivery device of claim 15, whereinthe driver comprising a threaded drive nut that is threadedly engagedwith the piston plunger such that rotation of the drive nut moves thefirst portion relative to the medicament container.